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510(k) K810938

MASS SPECTROMETER-MEDSPECT II by Allied Healthcare Products, Inc. — Product Code DOP

K810938 is an FDA 510(k) premarket notification submitted by Allied Healthcare Products, Inc. for the device "MASS SPECTROMETER-MEDSPECT II". The FDA issued a decision of Substantially Equivalent on April 23, 1981. The device falls under product code DOP (Mass Spectrometer, Clinical Use), a Class I device regulated under 21 CFR 862.2860. Allied Healthcare Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1981
Date Received
April 7, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mass Spectrometer, Clinical Use
Device Class
Class I
Regulation Number
862.2860
Review Panel
TX
Submission Type

Other clearances by Allied Healthcare Products, Inc.

  • K131098 — EMERGENCY PORTABLE VENTILATOR (April 9, 2014)
  • K132021 — AHP 300, EMERGENCY PORTABLE VENTILATOR (April 2, 2014)
  • K090356 — EMERGENCY PORTABLE VENTILATOR, MODEL EPV200 (May 20, 2009)
  • K083507 — BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS (May 18, 2009)
  • K083385 — MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B (May 14, 2009)
  • K080063 — MASS CASUALTY VENTILATOR, MODEL MCV100 (August 15, 2008)
  • K072214 — PORTABLE VENTILATOR, MODEL EPV-100 (March 6, 2008)
  • K073171 — RESUSCITATION TIMER, MODEL L770-CPR (January 31, 2008)
  • K070636 — AUTOVENT 4000 WITH CPAP (July 13, 2007)
  • K070120 — AUTOVENT MODEL 4000 (May 3, 2007)

Other clearances for product code DOP

  • K992163 — ABCA GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEMS (July 13, 1999)
  • K974322 — ABCA-NT GAS ISOTOPE RATIO MASS SPECTROMETER SYSTEM (December 16, 1997)
  • K880418 — INCOS 50 MASS SPECTROMETER (May 31, 1988)
  • K880090 — ION TRAP DETECTOR (March 15, 1988)
  • K880089 — FINNIGAN MAT TSQ-70 (February 11, 1988)
  • K872464 — ION TRAP DETECTOR (ITD) (August 11, 1987)
  • K854076 — MGA 2000 GAS ANALYSER (December 11, 1985)
  • K770994 — FURNACE AUTOSAMPLER, MODEL 155 (August 22, 1977)
  • K770637 — MERCURY/HYDRIDE SYSTEM MHS-1 (June 23, 1977)

FDA data resources